Menopause market draws billions while hormone therapy supplies run short

A market built on unmet demand

PwC expects the market to grow 8% to 10% a year through 2030, counting prescription drugs, over-the-counter products, self-tests and employer service packages.

The patient pool is not in doubt. The number of women in menopause worldwide should reach 1.2 billion by 2030. Private investment in the sector grew 15% a year over the past five years.

Employers have started treating menopause as a workforce issue. Vodafone has a menopause policy promising awareness and more flexible hours. SAP has folded menopause into its occupational health management, with training, digital information and individual consultations.

McKinsey Health Institute reckons women could gain seven additional healthy years if prevention, menopause care and workplace health were expanded. Gerard Richter is a senior partner at McKinsey. He told Handelsblatt that each dollar invested in women's health generates about three dollars of economic growth.

The supply side is already straining

None of that investment has made patches easier to find. The FDA said in September it was working with all six manufacturers of FDA-approved estradiol patches to increase production. The American Society of Health-System Pharmacists has listed the patches as being in shortage since January.

Supply has grown, just not fast enough. Patch supply had nearly doubled over the previous year, the FDA said, but the increase had not kept pace with demand, El Cronista reported on 30 October.

The problem has spread past patches. ASHP listed several estradiol valerate injection products from Hikma, American Regent and Par Sterile Products as being in shortage in early September. The organisation also reported supply disruptions involving vaginal estradiol creams made by Viatris' Mylan unit, Padagis and Teva, with some products on back order or subject to allocation. CVS Health said manufacturers had struggled for several months to provide enough of certain strengths of estradiol injections, and that the situation had worsened in recent weeks.

The pattern repeats outside the US. Selna du Plessis, a pharmacist at Geneva Pharmacy in South Africa, said hormone replacement therapy and contraceptives, including patches, have been hard to obtain for six months. She told the George Herald that eye drops and certain blood pressure medicines have also been in short supply.

Why patches are hard to scale

Patches are not a product line that scales quickly. They require specialised equipment and are low-margin generics, manufacturers say.

Upstream, the industry carries a structural dependency. The majority of active pharmaceutical ingredients are made primarily in China and India. That leaves domestic drug supplies exposed to single points of failure, Contract Pharma reported on 2 November.

Qualification is the bottleneck. Danny Goad, senior manager of supply chain management at PCI Pharma Services, put the problem plainly. A material may have several qualified suppliers on paper, but that does not necessarily translate into genuine supply resilience, he said. Regulatory requirements, lengthy qualification processes, intellectual property considerations, specialised manufacturing processes and limited global capacity can all make switching suppliers slow and difficult, he said.

Geography adds another layer. Goad said heavy reliance on one region for critical starting materials or APIs exposes supply chains to several risks. He listed geopolitical disruption, trade restrictions and costs, transport constraints, natural disasters and local regulatory changes. Those risks became visible during the pandemic and have kept evolving through tariffs and other trade measures, he said.

The regulatory trigger

Demand did not rise by accident. In November 2025 the FDA asked manufacturers to remove certain risk statements about cardiovascular disease, breast cancer and probable dementia from the boxed warning on hormone therapy labels. In February 2026 the agency approved the changes for a first group of six products. The warnings had rested on findings from the Women's Health Initiative study, published in 2002.

The revision contributed to renewed interest in treatments that women had previously approached with more caution, El Cronista reported. More prescriptions met a manufacturing base that had not kept up.

South Africa has taken a different route. South Africa's regulator, the South African Health Products Regulatory Authority, has granted Section 21 approval for emergency use of certain unregistered medicines. The approval applies where registered products are unavailable and no therapeutic alternative exists, according to the National Department of Health's contract management unit. Those approvals expire at different points between November 2026 and April 2027.

What happens next

The FDA has not declared an official shortage. It says the patches remain available, though availability varies by pharmacy.

That leaves patients and prescribers without a national allocation system, and the practical work of finding a substitute falls to individual pharmacies and clinicians. The contract management unit attributes the shortages to supply chain challenges. Its measures include sourcing medicines from additional manufacturers, promoting rational use of available stock and obtaining Sahpra authorisation to import where necessary.

For now, the money and the medicine are moving at different speeds, and the gap is being managed pharmacy by pharmacy.